Back to resultsA Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder
Primary Purpose
Adhesive Capsulitis
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Corticosteroid
ActiveMatrix
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Frozen Shoulder, musculoskeletal injuries
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the C5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder Have no contraindications or allergies to the treatment administered Have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the "freezing" stage of adhesive capsulitis). Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses. Exclusion Criteria: Any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy Evidence, based on MRI or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis) A history of significant trauma to the shoulder Poorly controlled diabetes mellitus, as defined by HbA1c > 7.5 mmol/L and glucose > 200 mg/dL. For diabetic participants HbA1c and glucose levels will be measured prior to intervention and documented for later analysis. For non-diabetic participants, previous labs will be utilized. All other medical diseases will be documented for later analysis. History of Cardiovascular Accident (CVA) such as stroke or Transient Ischemic Attack (TIA) Blood dyscrasias Use of any NSAIDs besides Tylenol. A letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study Prior shoulder surgery
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intra-articular Injection of Corticosteroid Plus Lidocaine
Intra-articular Injection of ActiveMatrix Plus Lidocaine
Arm Description
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
Outcomes
Primary Outcome Measures
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Secondary Outcome Measures
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Full Information
NCT ID
NCT05844930
First Posted
April 21, 2023
Last Updated
April 21, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Skye Biologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05844930
Brief Title
A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder
Official Title
Double Blinded Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) vs. Standard of Care in Adhesive Capsulitis of the Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Skye Biologics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to compare ActiveMatrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Frozen Shoulder, musculoskeletal injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-articular Injection of Corticosteroid Plus Lidocaine
Arm Type
Active Comparator
Arm Description
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Arm Title
Intra-articular Injection of ActiveMatrix Plus Lidocaine
Arm Type
Experimental
Arm Description
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Other Intervention Name(s)
Triamcinolone
Intervention Description
Triamcinolone 20 mg (1cc)
Intervention Type
Other
Intervention Name(s)
ActiveMatrix
Other Intervention Name(s)
Human Placental Connective Tissue-Derived Allograft
Intervention Description
1cc ActiveMatrix (Skye Biologics, Inc.)
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine 10 mg/mL (5cc)
Primary Outcome Measure Information:
Title
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
Description
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Time Frame
Baseline
Title
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
Description
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Time Frame
4 weeks following injection
Title
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
Description
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Time Frame
12 weeks following injection
Title
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
Description
SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability.
Time Frame
6 months following injection
Secondary Outcome Measure Information:
Title
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Description
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Time Frame
Baseline
Title
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Description
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Time Frame
4 weeks following injection
Title
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Description
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Time Frame
12 weeks following injection
Title
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Description
VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity.
Time Frame
6 months following injection
Title
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
Description
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Time Frame
Baseline
Title
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
Description
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Time Frame
4 weeks following injection
Title
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
Description
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Time Frame
12 weeks following injection
Title
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
Description
A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees.
Time Frame
6 months following injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the C5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder
Have no contraindications or allergies to the treatment administered
Have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the "freezing" stage of adhesive capsulitis).
Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses.
Exclusion Criteria:
Any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy
Evidence, based on MRI or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis)
A history of significant trauma to the shoulder
Poorly controlled diabetes mellitus, as defined by HbA1c > 7.5 mmol/L and glucose > 200 mg/dL. For diabetic participants HbA1c and glucose levels will be measured prior to intervention and documented for later analysis. For non-diabetic participants, previous labs will be utilized. All other medical diseases will be documented for later analysis.
History of Cardiovascular Accident (CVA) such as stroke or Transient Ischemic Attack (TIA)
Blood dyscrasias
Use of any NSAIDs besides Tylenol. A letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study
Prior shoulder surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric F Berkman, MD
Phone
713-314-4112
Email
Eric.F.Berkman@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Layla Haidar
Phone
713-486-5529
Email
Layla.Haidar@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric F Berkman, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric F Berkman, MD
Phone
713-314-4112
Email
Eric.F.Berkman@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Layla Haidar
Phone
713-486-5529
Email
Layla.Haidar@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder
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